India

India's patent system primarily covers invention patents: **Patent:** - Term: 20 years from filing date - Requires substantive examination (Request for Examination must be filed within 48 months) - Covers novel, inventive, industrially applicable product/method inventions **Non-Patentable Subject Matter (§ 3):** Section 3 of the Indian Patents Act explicitly lists non-patentable subject matter, including: - New forms of known substances unless significantly different efficacy is shown — the "anti-evergreening" provision targeting pharmaceutical patents - Mere discoveries (without technical effect) - Mathematical methods, business methods, computer programs per se (though computer-implemented inventions with technical character may be patentable) - Surgical methods **Designs:** - Separately administered by the Patent Office; 10-year term (renewable to 15 years)

Source: India Patents Act 1970, § 3; Indian Patent Office guidelines

Indian patent applications do not automatically enter examination. Applicants **must file a Request for Examination (RFE) within 48 months** of the filing date (or PCT international filing date), with the applicable fee. Failure to file the RFE by the deadline results in the application being deemed abandoned. After the RFE, the examiner issues a First Examination Report (FER). The applicant must respond within the prescribed period (standard 6 months, extendable to a maximum of 9 months).

Source: India Patents Act 1970 Rule 24B; IPO India guidelines

This is a unique requirement of the Indian patent system: **every Indian patent holder (including licensees) must file a Statement of Working (Form 27) within 3 months after the end of each financial year** (i.e., by September 30 each year), reporting the commercial working of the patent in India. If the patent is not commercially worked in India, the reasons and development plans must be stated. **Consequences of non-compliance:** May be treated as a violation of the Patents Act, potentially affecting compulsory licensing applications. Enforcement has received increasing attention in recent years.

Source: India Patents Act 1970 § 146; Rule 131 — Form 27

- Deadline: **31 months** from the priority date - The application must be in English (or with an English translation if the original is in another language) - National phase entry fees must be paid - After entry, a Request for Examination must still be filed within 48 months of the original PCT international filing date - Matters before the Indian Patent Office typically require a registered Indian patent agent

Source: WIPO PCT Applicant's Guide — IN; India Patents Act

India's Patents Act has a robust compulsory licensing (CL) system. After 3 years from the patent grant date, any person may apply to the Patent Office for a compulsory license if: - Reasonable requirements of the public have not been satisfied - The patented invention is not available at a reasonably affordable price - The patented invention is not worked in the territory of India **The 2012 Bayer v. Natco case** was India's first granted compulsory license (for a cancer drug, on affordability grounds). This case demonstrated India's willingness to grant CLs in public health contexts.

Source: India Patents Act 1970 §§ 84–92; Bayer Corp v. Natco Pharma Ltd (2012)

India's patent system provides two tiers of opposition: **Pre-Grant Opposition:** - Any person may file before patent grant (after the application is published) - Filed in writing; reviewed by the Patent Office - Particularly common in the pharmaceutical sector, used to challenge new form/use patents of known substances **Post-Grant Opposition:** - Must be filed within 12 months of the patent grant - Only an "interested person" may file - Adjudicated by an Opposition Board

Source: India Patents Act 1970 §§ 25(1) and 25(2)

Indian patents require renewal fees starting after grant, continuing until expiry (20 years). Fees are due before each anniversary. A grace period for late payment applies (with surcharge).

Source: India Patents Act 1970; IPO India fee schedule

IPO India participates in WIPO DAS, allowing applicants to electronically transmit priority documents to other participants.

Source: WIPO DAS; IPO India DAS procedures